Trial Outcomes & Findings for A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough (NCT NCT02993822)

NCT ID: NCT02993822

Last Updated: 2022-04-26

Results Overview

Objective cough frequency measured by ambulatory cough monitoring device

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 315 participants
• Primary outcome timeframe: Baseline to Week 12
• Results posted on: 2022-04-26

Participant Flow

The first subject was enrolled (screened and consented) on 22-May-2017; the first subject was randomised on 31-Jan-2017. The last subject was enrolled on 28-Sep-2018. The last subject last visit (study completion) was 24-Jan-2019. Subjects were recruited from a mixture of specialised standalone clinics and clinics within hospitals.

Screening details: 488 subjects were screened, of whom 315 (64.5%) completed screening and were randomised. Screening failures occurred due to not meeting inclusion criteria (74 subjects [15.2%]) or exclusion criteria (79 subjects [16.2%]), withdrawal of consent (nine [1.8%] subjects) and AEs (2 [0.4%] subjects). All other reasons reported in individual subjects.

Participant milestones

Measure	Orvepitant 10mg Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Overall Study STARTED	79	78	79	79
Overall Study COMPLETED	69	74	69	75
Overall Study NOT COMPLETED	10	4	10	4

Reasons for withdrawal

Measure	Orvepitant 10mg Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Overall Study Lack of Efficacy	1	1	0	0
Overall Study Protocol Violation	1	0	0	0
Overall Study Unable to attend follow-up due to illness	0	0	0	1
Overall Study Adverse Event	3	1	7	0
Overall Study Withdrawal by Subject	4	2	2	3
Overall Study Lost to Follow-up	1	0	1	0

Baseline Characteristics

A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough

Baseline characteristics by cohort

Measure	Orvepitant 10mg n=79 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=78 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=79 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=79 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral	Total n=315 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	44 Participants n=7 Participants	56 Participants n=5 Participants	37 Participants n=4 Participants	183 Participants n=21 Participants
Age, Categorical >=65 years	33 Participants n=5 Participants	34 Participants n=7 Participants	23 Participants n=5 Participants	42 Participants n=4 Participants	132 Participants n=21 Participants
Age, Continuous	62.29 years STANDARD_DEVIATION 9.850 • n=5 Participants	59.86 years STANDARD_DEVIATION 13.173 • n=7 Participants	59.47 years STANDARD_DEVIATION 10.020 • n=5 Participants	62.24 years STANDARD_DEVIATION 11.815 • n=4 Participants	60.97 years STANDARD_DEVIATION 11.313 • n=21 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	69 Participants n=7 Participants	60 Participants n=5 Participants	59 Participants n=4 Participants	253 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants	20 Participants n=4 Participants	62 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants	74 Participants n=7 Participants	77 Participants n=5 Participants	74 Participants n=4 Participants	299 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants
Region of Enrollment North America	51 participants n=5 Participants	49 participants n=7 Participants	51 participants n=5 Participants	51 participants n=4 Participants	202 participants n=21 Participants
Region of Enrollment Europe	28 participants n=5 Participants	29 participants n=7 Participants	28 participants n=5 Participants	28 participants n=4 Participants	113 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

Objective cough frequency measured by ambulatory cough monitoring device

Outcome measures

Measure	Orvepitant 10mg n=66 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=72 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=67 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=70 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change From Baseline to Week 12 in Awake Objective Cough Frequency	-0.185 coughs per hour (log transformed) Standard Deviation 0.3258	-0.192 coughs per hour (log transformed) Standard Deviation 0.3405	-0.271 coughs per hour (log transformed) Standard Deviation 0.4055	-0.243 coughs per hour (log transformed) Standard Deviation 0.3225

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

Objective cough frequency measured by ambulatory cough monitoring device

Outcome measures

Measure	Orvepitant 10mg n=73 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=74 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=75 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=73 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline	-0.180 coughs per hour (log transformed) Standard Deviation 0.2791	-0.181 coughs per hour (log transformed) Standard Deviation 0.3142	-0.215 coughs per hour (log transformed) Standard Deviation 0.2515	-0.139 coughs per hour (log transformed) Standard Deviation 0.2892

SECONDARY outcome

Timeframe: Week 4

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

Objective cough frequency measured by ambulatory cough monitoring device

Outcome measures

Measure	Orvepitant 10mg n=68 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=77 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=75 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=72 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline	-0.188 coughs per hour (log transformed) Standard Deviation 0.3292	-0.231 coughs per hour (log transformed) Standard Deviation 0.3665	-0.211 coughs per hour (log transformed) Standard Deviation 0.2994	-0.169 coughs per hour (log transformed) Standard Deviation 0.2699

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 2 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=72 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=77 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=75 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=75 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline	2.41 Total score Standard Deviation 3.309	2.37 Total score Standard Deviation 3.252	2.93 Total score Standard Deviation 3.010	1.24 Total score Standard Deviation 2.714

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 4 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=68 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=77 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=74 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=76 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline	2.50 Total score Standard Deviation 3.416	2.15 Total score Standard Deviation 3.490	2.98 Total score Standard Deviation 3.163	1.61 Total score Standard Deviation 3.132

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 8 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=66 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=76 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=70 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=75 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline	2.78 Total score Standard Deviation 3.535	2.19 Total score Standard Deviation 3.602	2.82 Total score Standard Deviation 3.960	1.34 Total score Standard Deviation 3.222

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 12 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=66 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=74 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=67 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=74 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline	2.38 Total score Standard Deviation 3.609	2.09 Total score Standard Deviation 3.736	3.23 Total score Standard Deviation 4.007	1.50 Total score Standard Deviation 3.586

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=71 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=77 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=75 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=75 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time	-17.7 Score Standard Deviation 26.06	-10.5 Score Standard Deviation 27.78	-13.5 Score Standard Deviation 22.93	-6.3 Score Standard Deviation 19.24

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=68 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=77 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=75 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=76 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time	-17.9 Score Standard Deviation 27.11	-9.4 Score Standard Deviation 26.76	-15.9 Score Standard Deviation 25.02	-7.8 Score Standard Deviation 22.36

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=66 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=76 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=72 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=75 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time	-21.0 Score Standard Deviation 30.37	-9.9 Score Standard Deviation 29.57	-18.6 Score Standard Deviation 27.24	-8.2 Score Standard Deviation 23.58

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=66 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=74 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=68 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=73 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Day-time	-18.8 Score Standard Deviation 31.27	-11.6 Score Standard Deviation 27.33	-20.1 Score Standard Deviation 29.33	-10.6 Score Standard Deviation 24.46

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=71 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=77 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=75 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=75 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Night-time	-12.8 Score Standard Deviation 28.96	-7.8 Score Standard Deviation 26.76	-6.2 Score Standard Deviation 24.97	-3.9 Score Standard Deviation 27.62

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=68 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=77 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=75 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=76 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Night-time	-10.1 Score Standard Deviation 32.87	-7.9 Score Standard Deviation 27.52	-5.8 Score Standard Deviation 27.96	-2.7 Score Standard Deviation 27.99

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=66 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=76 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=72 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=75 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Night-time	-11.5 Score Standard Deviation 32.65	-6.8 Score Standard Deviation 29.07	-9.8 Score Standard Deviation 28.73	-2.2 Score Standard Deviation 28.95

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=66 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=74 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=68 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=73 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Night-time	-8.9 Score Standard Deviation 35.99	-7.1 Score Standard Deviation 26.88	-9.6 Score Standard Deviation 30.24	-1.5 Score Standard Deviation 33.74

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=72 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=77 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=75 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=74 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 2 Compared to Baseline	-20.8 Score Standard Deviation 24.59	-12.0 Score Standard Deviation 25.09	-13.8 Score Standard Deviation 22.03	-7.0 Score Standard Deviation 20.35

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=68 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=77 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=75 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=76 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 4 Compared to Baseline	-19.0 Score Standard Deviation 26.93	-12.0 Score Standard Deviation 26.67	-17.3 Score Standard Deviation 24.73	-8.8 Score Standard Deviation 24.26

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=65 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=76 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=72 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=75 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 8 Compared to Baseline	-23.8 Score Standard Deviation 28.00	-14.5 Score Standard Deviation 27.55	-19.7 Score Standard Deviation 26.80	-11.0 Score Standard Deviation 24.78

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=66 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=74 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=68 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=74 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 12 Compared to Baseline	-23.7 Score Standard Deviation 27.30	-12.6 Score Standard Deviation 28.57	-22.9 Score Standard Deviation 28.43	-11.8 Score Standard Deviation 26.50

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=73 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=77 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=76 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=74 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Global Rating of Change in Cough Frequency at Week 2 Worse	4 Participants	10 Participants	5 Participants	11 Participants
Global Rating of Change in Cough Frequency at Week 2 About the same	35 Participants	37 Participants	34 Participants	44 Participants
Global Rating of Change in Cough Frequency at Week 2 Better	34 Participants	30 Participants	37 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=69 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=76 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=74 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=76 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Global Rating of Change in Cough Frequency at Week 4 Worse	9 Participants	8 Participants	6 Participants	12 Participants
Global Rating of Change in Cough Frequency at Week 4 About the same	32 Participants	36 Participants	37 Participants	39 Participants
Global Rating of Change in Cough Frequency at Week 4 Better	28 Participants	32 Participants	31 Participants	25 Participants

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=67 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=75 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=72 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=75 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Global Rating of Change in Cough Frequency at Week 8 Worse	11 Participants	17 Participants	10 Participants	20 Participants
Global Rating of Change in Cough Frequency at Week 8 About the same	22 Participants	31 Participants	37 Participants	38 Participants
Global Rating of Change in Cough Frequency at Week 8 Better	34 Participants	27 Participants	25 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=67 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=74 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=67 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=74 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Global Rating of Change in Cough Frequency at Week 12 Worse	7 Participants	13 Participants	7 Participants	13 Participants
Global Rating of Change in Cough Frequency at Week 12 About the same	32 Participants	33 Participants	31 Participants	37 Participants
Global Rating of Change in Cough Frequency at Week 12 Better	28 Participants	28 Participants	29 Participants	24 Participants

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=73 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=77 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=76 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=74 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Global Rating of Change in Cough Severity at Week 2 Worse	7 Participants	8 Participants	4 Participants	12 Participants
Global Rating of Change in Cough Severity at Week 2 About the same	33 Participants	39 Participants	35 Participants	44 Participants
Global Rating of Change in Cough Severity at Week 2 Better	33 Participants	30 Participants	37 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=69 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=76 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=74 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=76 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Global Rating of Change in Cough Severity at Week 4 Worse	9 Participants	7 Participants	7 Participants	14 Participants
Global Rating of Change in Cough Severity at Week 4 About the same	32 Participants	43 Participants	31 Participants	37 Participants
Global Rating of Change in Cough Severity at Week 4 Better	28 Participants	26 Participants	36 Participants	25 Participants

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=67 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=75 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=72 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=75 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Global Rating of Change in Cough Severity at Week 8 Worse	8 Participants	12 Participants	6 Participants	15 Participants
Global Rating of Change in Cough Severity at Week 8 About the same	26 Participants	36 Participants	35 Participants	42 Participants
Global Rating of Change in Cough Severity at Week 8 Better	33 Participants	27 Participants	31 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).

In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.

Outcome measures

Measure	Orvepitant 10mg n=67 Participants Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=74 Participants Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=67 Participants Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=74 Participants Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Global Rating of Change in Cough Severity at Week 12 Worse	5 Participants	15 Participants	8 Participants	16 Participants
Global Rating of Change in Cough Severity at Week 12 About the same	38 Participants	33 Participants	30 Participants	36 Participants
Global Rating of Change in Cough Severity at Week 12 Better	24 Participants	26 Participants	29 Participants	22 Participants

Adverse Events

Orvepitant 10mg

Serious events: 1 serious events

Other events: 63 other events

Deaths: 0 deaths

Orvepitant 20mg

Serious events: 1 serious events

Other events: 48 other events

Deaths: 0 deaths

Orvepitant 30mg

Serious events: 3 serious events

Other events: 53 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Measure	Orvepitant 10mg n=79 participants at risk Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=78 participants at risk Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=79 participants at risk Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=79 participants at risk Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Injury, poisoning and procedural complications Intestinal anastomosis complication	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/78 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	1.3% 1/79 • Number of events 1 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Vascular disorders Hypertension	1.3% 1/79 • Number of events 1 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/78 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Cardiac disorders Bradycardia	1.3% 1/79 • Number of events 1 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/78 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/78 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	1.3% 1/79 • Number of events 1 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Psychiatric disorders Suicide attempt	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/78 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	1.3% 1/79 • Number of events 1 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Psychiatric disorders Anxiety	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/78 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	1.3% 1/79 • Number of events 1 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Metabolism and nutrition disorders Dehydration	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	1.3% 1/78 • Number of events 1 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.

Other adverse events

Measure	Orvepitant 10mg n=79 participants at risk Orvepitant 10mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 20mg n=78 participants at risk Orvepitant 20mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Orvepitant 30mg n=79 participants at risk Orvepitant 30mg tablet, once daily for 12 weeks Orvepitant Maleate: Tablet, once daily, oral	Placebo n=79 participants at risk Placebo to match tablet, once daily for 12 weeks Placebo: Tablet, once daily, oral
Nervous system disorders Somnolence	2.5% 2/79 • Number of events 2 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	5.1% 4/78 • Number of events 4 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	6.3% 5/79 • Number of events 5 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Nervous system disorders Paraesthesia	5.1% 4/79 • Number of events 4 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/78 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	1.3% 1/79 • Number of events 1 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.3% 5/79 • Number of events 6 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	1.3% 1/78 • Number of events 2 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	5.1% 4/79 • Number of events 5 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	3.8% 3/79 • Number of events 3 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Nervous system disorders Headache	8.9% 7/79 • Number of events 7 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	12.8% 10/78 • Number of events 19 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	8.9% 7/79 • Number of events 9 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	5.1% 4/79 • Number of events 6 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Nervous system disorders Dizziness	6.3% 5/79 • Number of events 5 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	5.1% 4/78 • Number of events 4 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	6.3% 5/79 • Number of events 6 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	1.3% 1/79 • Number of events 1 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
General disorders Fatigue	16.5% 13/79 • Number of events 14 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	16.7% 13/78 • Number of events 14 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	13.9% 11/79 • Number of events 11 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	5.1% 4/79 • Number of events 4 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Gastrointestinal disorders Nausea	2.5% 2/79 • Number of events 2 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	1.3% 1/78 • Number of events 1 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	5.1% 4/79 • Number of events 4 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	3.8% 3/79 • Number of events 4 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Musculoskeletal and connective tissue disorders Back pain	5.1% 4/79 • Number of events 4 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	1.3% 1/78 • Number of events 1 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	7.6% 6/79 • Number of events 6 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	0.00% 0/79 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	5.1% 4/79 • Number of events 4 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	1.3% 1/78 • Number of events 1 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	1.3% 1/79 • Number of events 1 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	1.3% 1/79 • Number of events 1 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Infections and infestations Viral upper respiratory tract infection	10.1% 8/79 • Number of events 9 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	9.0% 7/78 • Number of events 10 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	5.1% 4/79 • Number of events 4 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	12.7% 10/79 • Number of events 11 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Infections and infestations Upper respiratory tract infection	6.3% 5/79 • Number of events 6 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	5.1% 4/78 • Number of events 5 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	3.8% 3/79 • Number of events 3 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	11.4% 9/79 • Number of events 9 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.
Infections and infestations Urinary tract infection	5.1% 4/79 • Number of events 4 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	2.6% 2/78 • Number of events 2 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	3.8% 3/79 • Number of events 4 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.	5.1% 4/79 • Number of events 4 • Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks. Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.

Additional Information

Dr. Stephen Pawsey

NeRRe Therapeutics Limited

Phone: +44 (0)1438906960

Email: steve.pawsey@nerretherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60